tbuckley/cabot-search huggingface dataset:
An overview of adverse event (AE) management for patients (pts) receiving abemaciclib.
Authors: Hope S. Rugo, Alexandra Vitko, Kelli Thoele
Journal: Journal of Clinical Oncology (2022)

239 Background: Abemaciclib is a selective cyclin-dependent kinase 4 &amp; 6 inhibitor, approved for hormone receptor-positive (HR+), HER2- advanced breast cancer (aBC) as monotherapy or in combination with fulvestrant or nonsteroidal aromatase inhibitors. Abemaciclib is also approved in combination with endocrine therapy for the adjuvant treatment of HR+, HER2-, node-positive, high risk early BC (EBC). Despite demonstrated efficacy and overall tolerable safety profile, some pts discontinue abemaciclib without a prior dose reduction, highlighting the need for appropriate symptom management. This analysis aims to provide guidance on management of AEs for pts with aBC or EBC receiving abemaciclib. Methods: Study level data were collected for publications related to MONARCH 1, 2, and 3, and monarchE clinical trials. Endpoints included incidence of any-grade AEs, dose modifications, and discontinuations. Data on monitoring of AEs were also extracted. Results are presented descriptively. Results: Highest any-grade incidence of abemaciclib-associated AEs across trials include diarrhea (82-90%), fatigue (41-65%), nausea (30-64%) and neutropenia (37-50%). Notable AEs leading to dose reduction, omission and discontinuation were: diarrhea (14-21%; 15-24%; 1-5%), neutropenia (8-13%; 16-17%; 1-3%), and fatigue (5%; 5%; 2%) respectively. In the monarchE trial, discontinuations due to AEs were highest in the first month and stabilized after 6 months. AE monitoring and management are presented in Table. Conclusions: Appropriate AE monitoring, symptom management strategies, and patient counseling should be used to manage AEs with a goal to impact early discontinuation of abemaciclib.[Table: see text]
COVID-19 impact on multiple myeloma prescribing patterns.
Authors: Dipti Shah, Kelly McAuliff, Elias Pittos, Amanda McCarthy, William Cavers, Rashmi Grover, Lucia Feczko, Elisea Avalos-Reyes, Kjel Andrew Johnson
Journal: Journal of Clinical Oncology (2022)

123 Background: COVID-19 has impacted several areas of oncology patient care, most notably the reduction of patient visits for treatments. Standard treatment of multiple myeloma (MM) involves a combination of intravenous (IV) and oral therapies. The purpose of this study is to assess the impact COVID-19 had on IV and oral medication prescribing patterns pre and during the COVID-19 pandemic among MM patients. Methods: This is a retrospective review of adult MM patients insured by a large commercial and Medicare health plan in the United States who started a new IV or oral MM agent during the study period. To assess the impact of COVID-19 on IV and oral medication prescribing patterns, we compareda pre-COVID period (March 1-August 31, 2019) to a COVID period (March 1-August 31, 2020). We utilized medical and pharmacy claims to identify patients and calculated new therapy starts per newly diagnosed patient (defined as the number of patients starting a new IV or oral medication for MM divided by the total number of patients with a first indication date of MM within the study timeframe). We compared rates using a Chi-square test; p-values ≤ 0.05 were considered statistically significant. Results: 1,754 patients were enrolled in the study; there were no significant differences in demographic characteristics pre and during COVID-19 between the two groups with respect to age (67.05 vs. 66.64; p = 0.45), gender (p = 0.80), insurance plan type (p = 0.17), geographical region (p = 0.26) and medication (p = 0.59). During COVID-19, the number of newly diagnosed MM patients decreased by 22% (9,657 to 7,560) and the total number of new therapy starts decreased by 11% (930 to 824). When looking at rates of new therapy starts per newly diagnosed patient, both IV (11%; p = 0.03) and oral (51%; p = 0.03) medication rates significantly increased. Additionally, there were significant increases in new therapy start rates by region in the Northeast for oral (157%; p &lt; 0.01) and West for IV (32%; p = 0.02) medications. There were no significant differences in new start rates by insurance plan type (all p &gt; 0.08). Conclusions: While the total count of new therapy starts, a proxy for new diagnoses, decreased during COVID-19, the rate of new starts for both IV and oral therapies for patients diagnosed with MM significantly increased. These increased start rates may be explained by a remarkable 22% drop in the total number of newly diagnosed MM patients during COVID-19. As the pandemic continues, further study is warranted to understand how COVID-19 may impact IV vs. oral usage in MM.[Table: see text]
Patient-reported outcomes: Completion, access, and equity.
Authors: Jessica McGuire, Harrison Taylor Hubbell, Ephraim P. Hochberg, Cara Foley, David P. Ryan, Therese Marie Mulvey
Journal: Journal of Clinical Oncology (2022)

141 Background: Patient Reported Outcomes CTCAE (PROM) completion has demonstrated improvements in survival for patients with advanced cancer. Little is known about completion rates by race and gender for questionnaires assigned to all patients receiving IV infusions. Methods: Beginning in 2019 all patients who had a visit associated with an IV infusion were assigned a PROM PRO-CTCAE questionnaire through the EHR portal 72 hours prior to the visit and again using an in- clinic tablet if not completed upon check-in. The PROMs questionnaires are available in 6 languages via both electronic platforms. At registration, all patients self- identify as White, Black/African American, Asian or other (multiple, do not prefer to answer) by race. We collected 2021 data on all eligible patients who were assigned a questionnaire and cross referenced that by completion and self-assigned race and gender at registration. Data from breast, thoracic and GI clinics are presented. Results: 1715 patients were eligible and self-identified as White, Black or Asian for a PROM CTCAE questionnaire across the three clinics (519 breast clinic, 390 thoracic, 806 GI). 3872 questionnaires were completed (average 2.26 questionnaires per eligible patient). 2875 (73%) were completed by EHR portal and 1027 (27%) were completed in clinic on the tablet. White patients completed questionnaires 67% when assigned, Asian 68% and Black/African American 52% of the time. 81% of breast clinic patients completed questionnaires, 62% of thoracic patients and 54% of GI patients. Overall, in thoracic and GI clinics White women completed questionnaires 58%, Black women 41% and Asian women 70% compared to White men 59%, Asian men 56% and Black men 57%. All patients who completed questionnaires in breast clinic identified as women. Conclusions: We assigned PROM CTCAE questionnaires to all eligible patients who had an IV infusion encounter associated with their visits in the breast, thoracic and GI clinics by both the electronic chart portal and again in clinic by tablet, if not completed prior to the in person visit. PROM questionnaires are available in 6 languages through both methods. We identified differences in completion rates by race with fewer African American/Black patient completion rates compared to White or Asian self-identification, (52% vs 67.5%). The largest differences were between White or Asian women, 58% and 70% completion rates compared to Black women 41%. Differences in gender may explain differences across disease groups as all breast clinic patients were self-identified as female, 81% completion rate compared to 62% thoracic and 54% GI.
Palliative care utilization in metastatic prostate cancer: An analysis of the National Cancer Database.
Authors: Xinxin Wu, Michelle Swedek, Timothy Dean Malouff, Peter T. Silberstein
Journal: Journal of Clinical Oncology (2022)

202 Background: Prostate cancer is one of the most prevalent cancers among males with an increasing incidence rate since 2007. Bone metastases are commonly associated with prostate cancer. Prostate cancer patients with painful bone metastases can be treated palliatively with external radiation being the standard of care. The role of palliative care can be beneficial in metastatic prostate cancer given its largely incurable course even after intensive multimodal therapy. There has yet to be a study that explores the impact of race, insurance status, education level, facility type, rural/urban geography, and income level on the overall utilization of palliative care for the cancer, the palliative treatment the patients were more likely to receive based on the different demographic variables, and the palliative care disparity between socioeconomic groups. Methods: This is a retrospective study of adults diagnosed with all subtypes of AJCC staged metastatic prostate cancer between 2004 and 2017 in the National Cancer Database (NCDB) to determine palliative care usage (n = 64,268). Demographic factors were studied in relation to the receipt of palliative care. Cross tabulation analysis was performed and evaluated using Pearson Chi-Square and ANOVA tests. Kaplan-Meier curves were utilized to calculate survival probabilities with log-rank analysis. Exclusion criteria included concurrent tumors and missing data. Results: Approximately 15.8% of the patients diagnosed with metastatic prostate cancer received palliative care (10180/64268). The number of cases diagnosed has grown every year between 2004 (n = 2140) and 2017 (n = 6,961). The same pattern was seen for palliative care usage in these patients (n = 352 in 2004 and n = 1325 in 2017). The patients that did not receive palliative care were older (71.3 vs 70.7, range 40-90+, p &lt; 0.001). The patients who did receive PC were more likely to be non-Hispanic (94.6%, p &lt; 0.001), white (78.6%, p &lt; 0.001) patients at a comprehensive community cancer program (40.9%, p &lt; 0.001). Palliative care was more likely utilized in rural settings (2% vs 1.6%, p &lt; 0.001), higher Charlson-Deyo score (0.41 vs 0.38, p &lt; 0.001), all facility locations excluding Mountain or Pacific, lower levels of high school degree attainment, lower overall survival, and those in age groups ranged 40-49, 50-59, and 60-69. There was no statistical significant difference in great circle distance between those that utilized palliative care and those that did not. Conclusions: We identified trends among patients receiving palliative or not. Factors that were correlated with palliative care usage included race, Charlson-Deyo score, treatment facility type, region, education level, rural setting, and specific age groups. As palliative care continues to be utilized more frequently, we hope that this study can serve as a useful baseline for preventing disparities in care.
Advice from one patient to another: A qualitative analysis of patients’ perspectives about chemotherapy initiation.
Authors: Catalina Malinowski, Ashley Housten, Edna Paredes, Mariana Chavez Mac Gregor
Journal: Journal of Clinical Oncology (2022)

255 Background: Although the association between delays in (neo)adjuvant chemotherapy initiation and adverse outcomes is well-documented, research into what those with breast cancer experience during their delay is sparse. This information can provide insight for newly diagnosed women on preparing for chemotherapy initiation and inform potential interventions to facilitate chemotherapy initiation. This study aimed to assess and identify the multilevel factors contributing to the barriers and facilitators of initiating chemotherapy. We present a qualitative exploration of patient shared experiences navigating the cancer care journey from breast cancer diagnosis to treatment activation. Methods: In this qualitative study, we included English or Spanish-speaking women diagnosed with primary invasive breast cancer who experienced chemotherapy initiation delay. We conducted semi-structured interviews exploring perceptions about individual, community, and system-level barriers and facilitators contributing to starting chemotherapy. We prompted participants to reflect on their personal experience navigating their cancer journeys from initial diagnosis to treatment initiation. Interviews were audio-recorded, transcribed verbatim, and coded using the Sort and Sift, Think and Shift qualitative approach to identify concepts and themes within and across transcripts. Results: Twenty-two participants completed semi-structured interviews and questionnaires (range 27-70 years); they identified as Latina (n = 8), Black (n = 5), and non-Latina White (n = 9). Our participants thought that engaging their medical teams and seeking support earlier was essential for their treatment journeys. They emphasized being proactive and thorough in all aspects of their journey, particularly in processing medical recommendations, communicating with medical personnel, and identifying areas of need. Although explicit insight into chemotherapy delay was rare, participants expressed the importance of beginning treatment promptly. They shared advice on acquiring support (e.g., financial, emotional, logistical, spiritual) and suggested connecting with breast cancer survivors to overcome the complex challenges of cancer care. Conclusions: Patients outlined the benefit of attaining support outside of their medical teams to overcome barriers and initiate treatment promptly. Family, friends, and connecting with breast cancer survivors were vital in achieving activation. Patient perspectives regarding barriers and treatment facilitators are an essential insight into cancer care journeys that can inform interventions to support patients and improve outcomes. We are using these results to develop a pilot study, to test the acceptability and feasibility of a culturally relevant patient navigation intervention to increase self-efficacy and avoid treatment delays.
Oncology-specific Qualified Clinical Data Registry (QCDR) measures to advance cancer care and achieve Merit-Based Incentive Payment System (MIPS) performance.
Authors: Erin Crum, Taylor Adams, Robyn Harrell, Stuart Staggs, Lalan S. Wilfong
Journal: Journal of Clinical Oncology (2022)

435 Background: Quality measurement is one of the four pillars of the Centers for Medicare and Medicaid (CMS) MIPS program. Few MIPS quality measures are specific to oncology. The US Oncology Network (USON) in collaboration with McKesson created a QCDR to align quality improvement reporting with oncology-specific measures to improve cancer care. Methods: The Practice Insights QCDR application was developed and submitted to CMS for approval in 2017. Integrated with an oncology-specific EHR (iKnowMed Generation 2), the QCDR leverages clinical content to automate calculation of quality measures. A multidisciplinary team was created to develop targeted oncology-specific measures that are clinically relevant, improve patient care, and reduce unnecessary healthcare costs. Results: The QCDR has been approved by CMS since 2017 allowing development of oncology-specific measures to monitor critical areas of cancer care. USON practices reported these measures as part of their MIPS participation. CMS established national MIPS program performance benchmarks for 4 measures due to measure feasibility, reporting ease, and high clinician adoption rates. PIMSH4 Pain Improvement (patient-reported outcome) was selected for public reporting through CMS Care Compare. CMS approved all 7 submitted QCDR measures for the 2022 MIPS program year. USON average performance (25 practices, representing 1,787 clinicians) from 2019-2022 YTD demonstrates significant improvement ranging from 4%-10%. Conclusions: Creating an oncologic-specific QCDR allowed USON practices to report more meaningful quality measures through the MIPS program. QCDR measures provide insight for care teams and trends from 2019-2022 YTD demonstrate that USON practices achieved significant performance improvements in key areas of cancer care. Future development will refine and identify new measures that align with our patient care improvement activities to enable clinicians and care teams to focus on measures that matter.[Table: see text]
Analysis of increased paclitaxel hypersensitivity at a single institution in setting of COVID 19 vaccination.
Authors: Nikita Jain, Anika Bhargava, Kelly Weaver, Lesley Volz, Brette Conliffe, Lauren Ingles, Brian Dong
Journal: Journal of Clinical Oncology (2022)

364 Background: Paclitaxel is a commonly used chemotherapy agent effective in various malignancies. It is known to cause serious and potentially life-threatening hypersensitivity reactions (HRs). Pre-medication protocols have been employed, however approximately 10% of patients will still experience these reactions (1). On an internal review at the University of Louisville, Brown Cancer Center (UofL, BCC) there has been a considerable increase in the incidence of paclitaxel HRs from 4.2% in March 2020 - March 2021 to 14.8% in March 2021 - April 2022. Identifying risk factors that may predispose patients to these reactions is an area of interest in an effort to reduce these events. In this study we investigated clinical characteristics between patients that tolerated paclitaxel versus those who had a HR within the last year with a particular focus on the COVID-19 vaccine given the recent pandemic. Methods: This is a single center retrospective case-control study done at the UofL, BCC. Data was collected on patients who received cycle one day one paclitaxel from March 2021 to April 2022 (n = 135), and patients who developed a reaction were identified. Patient characteristics including demographics, COVID vaccination status, and prior allergies were also collected (table). A T-test analysis was performed between the two groups – those who had a HR and those who did not. Results: Of the 135 patients, 20 were found to have a HR. Absolute lymphocyte count (ALC) was found to be significantly higher with an average of 1125 in the HR group versus 853 in the no reaction group (p = 0.0357). Patients in the HR group also had fewer lines of chemotherapy with an average of 1.15 versus the no reaction group of 1.4 (p = 0.039). There was no significant difference between patients who received the COVID-19 vaccine and those who did not (table). Conclusions: Patients who experienced paclitaxel HRs were found to have higher levels of ALC and tend to be earlier in their treatment course with having undergone fewer lines of chemotherapy. Of note COVID-19 vaccination status appears to have no association with those experiencing paclitaxel HRs. The clinical implications of this requires further exploration in future studies[Table: see text]
Creation of standard work for the management of outpatient oral antineoplastic therapy.
Authors: Junid Naveed Naveed Ahmad, Nicole Whalen, Karen Hemeon, Joseph Grant F Rosales
Journal: Journal of Clinical Oncology (2022)

369 Background: Recently, there has been a dramatic increase in the use of oral antineoplastics for the treatment of various malignancies. The development of these agents has been so rapid that the infrastructure needed for their appropriate supervision has trailed their availability. Previously at Virginia Mason, there was no standard work established for the management of patients starting these agents and consequently there were defects noted, including delays in the medications’ delivery to the patient, lack of appropriate teaching regarding potential medication toxicities and even delayed provider follow-up. The goal of this project was to create standard work around the treatment initiation and follow-up of all patients starting outpatient oral antineoplastic therapy. Methods: A multi-disciplinary team of providers, nurses, and pharmacists held a flow mapping session to identify defects and waste points in the process between the prescription being written until the first provider follow-up visit after medication delivery. The team focused on decreasing the amount of time between prescription initiation and first clinic follow up, as well as increasing the percentage of RN teaching sessions performed and documented. This involved the creation of a dedicated inbox in the Electronic Medical Record (EMR) to which pharmacy and care manager nurses had exclusive access to facilitate rapid communication between team members. The work also resulted in the creation of an antineoplastics teaching template which was used to document teaching on potential treatment toxicities. Results: Standard work was created for the outpatient oral antineoplastic administration process and teaching documentation. Using the new tools, lead time was improved by 21.7% and teaching documentation was improved by 185% at the 30-day mark. These metrics were monitored over a 3 month period, and at the end of 90 days the lead time improvement was maintained at 21.2% and teaching documentation improvement at 110% (Table). Conclusions: The rapid development of oral antineoplastic medications has required Oncology practices to develop more robust workflow infrastructure to administer these medications properly and safely. We created standard work for the proper initiation and follow-up of oral antineoplastic therapy. In doing so we identified specific defects and instances of waste and were able to improve the workflow process to address these issues, resulting in measurable quality improvements and overall better patient care.[Table: see text]